Form 6-K SciSparc Ltd./ADR For: Jul 28

July 28, 2021 4:01 PM EDT

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of July 2021 (Report No. 4)

 

Commission file number: 001- 38041

 

SCISPARC LTD.

(Translation of registrant’s name into English)

 

20 Raul Wallenberg Street, Tower A,

Tel Aviv 6971916 Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F    Form 40-F

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

 

Note: Regulation S-T Rule 101(b)( 1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR. 

 

 

 

 

 

CONTENTS

 

On July 26, 2021, SciSparc Ltd. (the “Company”) issued a press release titled: “SciSparc Announces Updates Regarding its Phase IIb Study in Tourette Syndrome”. A copy of this press release is furnished herewith as Exhibit 99.1.

 

This Report on Form 6-K is incorporated by reference into the registration statements on Form F-3 (File No. 333-225745 and File No. 333-233417) and on Form S-8 (File No. 333-225773) of the Company, filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

1 

 

 

EXHIBIT INDEX

 

Exhibit No.    
99.1   Press release titled: “SciSparc Announces Updates Regarding its Phase IIb Study in Tourette Syndrome”.

 

2 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  SciSparc Ltd.
   
Date: July 28, 2021 By:  /s/Oz Adler
    Name:  Oz Adler
    Title: Chief Financial Officer

 

3 

Exhibit 99.1 

SciSparc Announces Updates Regarding its Phase IIb Study in Tourette Syndrome

 

SciSparc intends to evaluate the efficacy, safety and tolerability of its Proprietary Cannabinoid-Based Treatment- SCI-110

 

TEL AVIV, Israel, July 26, 2021 /PRNewswire/ -- SciSparc Ltd. (OTCQB: SPRCY), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, today announced a number of updates regarding its Phase IIb clinical study in Tourette Syndrome using the proprietary cannabinoid-based treatment- SCI-110.

SciSparc Ltd Logo

The company has begun preparation that will facilitate the commencement of the clinical study and engaged with a contract research organization (CRO) to provide support for the trial.

 

In addition, SciSparc had established its supply chain infrastructure for the manufacturing and delivering of the SCI-110 drug.

 

The company is currently in contact with two clinical sites that will potentially host and conduct the clinical study.  

 

Tourette Syndrome (TS) is a movement and neurobehavioral disorder characterized by motor and vocal chronic tics with onset before age 18. About half to two-thirds of the cases get much better during adolescence[1]; however, adults will generally be more severe patients[2]. Tics may be associated with a premonitory sensation to perform the specific action, which may lead to "relief" once performed.

 

SciSparc intends to evaluate the efficacy, safety and tolerability of its SCI-110 in a randomized, double-blind, placebo controlled, cross-over study. The patients will be randomized in 1:1 ratio to receive either SCI-110 or SCI-110 matched placebo. The primary efficacy objective of the study will be to assess change in YGTSS-R-TTS[3] as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the study will be to assess absolute and relative frequencies of Serious Adverse Events (SAEs) for the whole population and separately for SCI-110 and placebo groups.

 

About SciSparc (OTCQB: SPRCY):

 

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. Our focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 (formerly THX-110) for the treatment of Tourette syndrome and for the treatment of obstructive sleep apnea; SCI-160 (formerly THX-160) for the treatment of pain; and SCI-210 (formerly THX-210) for the treatment of autism spectrum disorder and epilepsy.

 

 

 

 

Forward-Looking Statements:

 

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses the expected clinical study for SCI-110 and the potential efficacy, safety of SCI-110. Historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on March 30, 2021, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

 

Investor Contact:

IR@scisparc.com
Tel: +972-3-6167055

 

[1] https://www.pharmacytimes.com/publications/issue/2010/march2010/rxfocustourettes-0310

 

[2] https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tourette-Syndrome-Fact-Sheet#3231

 

[3] Yale Global Tic Severity Scale-Revised-Total Tic-Score- A psychological measure designed to assess the severity and frequency of symptoms of disorders such as Tourette syndrome

 

Logo - https://mma.prnewswire.com/media/1434686/SciSparc_Ltd_Logo.jpg

 

 

 



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